New York, NY, USA
23 days ago
A Stealth Biotech in the Greater New York City area is currently searching for a Vice President of Global Regulatory Affairs to lead their Regulatory function.
This role will report into the CEO and will have Quality & Compliance oversight. It is an extremely exciting time to join this company.
The lead program will be an extremely high visibility program with a completely novel therapeutic approach and efficacy already demonstrated in the clinic.
- Provide strategic regulatory leadership and maintain global responsibility for all development projects, including regulatory strategy, regulatory requirements for global registration, and regulatory risk assessments and mitigation for all programs
- Prepare and develop plans and registration strategies that will ensure worldwide regulatory submissions that align with key business objectives
- Prepare briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs, and annual reports
- Provide regulatory strategy and input to all non-clinical and clinical programs including clinical, toxicology, pharmacology and CMC
- Ensure that all the manufacturing and quality programs relevant to CMC/Pharmaceutical development are structured appropriately for regulatory requirements
- Anticipate the impact of the changing domestic and international regulatory environment, existing legislation and guidelines on the development of plans, registration strategies and post-marketing maintenance in order to execute program objectives in compliance with applicable regulations
- Ensure the safe, compliant, and robust integration of documentation from new product acquisitions and due diligence activities
- Initiate and contribute to the development of policies and procedures in compliance with GxPs etc.
- Oversee Quality & Compliance staff
- Collaborate with clinical, commercial, CMC, business development, and Legal in the development of strategies to strengthen the exclusivity of the company’s IP
- Ensure that biologic programs receive regulatory approval by key regulatory bodies in the US, EU, Asia, and Latin America
- Advanced degree in a science-related discipline or relevant experience demonstrating scientific competence
- 15+ years of pharmaceutical industry experience, at least 10 of which include regulatory responsibilities
- Rare Disease experience a plus
- Strong knowledge of current US and EU regulations, including novel regulatory pathways
- Strong experience with CTD format and content regulatory filings
- Thorough knowledge of the drug development process, with a focus on IND/CTA and NDA/BLA/MAA processes
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance (preferably from at least both US and EU)
- Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required
- Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11 and ICH Quality guidelines